DOCUSATE SODIUM- docusate sodium capsule 
NCS HealthCare of KY, Inc dba Vangard Labs

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Docusate Sodium 250mg

Active ingredient (in each softgel)

Docusate Sodium 250mg

Purpose

Stool Softener

Uses

• for the prevention of dry, hard stools.

• for relief of occasional constipation

• this product generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

• if you are currently taking mineral oil, unless directed by a doctor

• when abdominal pain, nausea, or vomiting are present

• for more than 1 week, unless directed by a doctor

Ask a doctor before use if

you notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if

• you have rectal bleeding

• you fail to have a bowel movement after use

If pregnant or breastfeeding

ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

• adults and children over 12 years of age and over: take 1 softgel daily or as directed by a doctor

• children under 12 years of age: take as directed by a doctor

Other information

• each softgel contains: sodium 15mg

• store at controlled room temperature 15° - 30° C (59° - 86° F)

• do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

edible white ink, FD&C Red # 40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.

Questions?

Adverse Drug Event Call: (800) 616-2471

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150, USA

Principal Display Panel

Docusate Sodium Softgel Caps 250mg

Principal Display Panel-Docusate Sodium Softgel Capsule 250mg
DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-0586(NDC:0904-7891)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 250 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
Product Characteristics
Color RED (Orange) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code P20
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0615-0586-39 30 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 07/01/2010
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 RELABEL(0615-0586) , REPACK(0615-0586)

Revised: 2/2014
Document Id: fbf5de0e-45c0-4ba9-8557-70d82de4e3ae
Set id: a753c56b-17c0-4451-9d4f-ba359de3af22
Version: 11
Effective Time: 20140204
 
NCS HealthCare of KY, Inc dba Vangard Labs